Regulatory Affairs Specialist Jobs in Hopewell, NJ
The Director of Regulatory Affairs in the quality control industry plays an essential role in ensuring that the company's products meet all regulatory standards and compliance requirements. This individual oversees the development and implementation of regulatory strategies for new and existing products, supervises the preparation of regulatory submissions, and maintains communication with regulatory authorities. They also monitor changes in regulations, interpret these updates for relevant departments within the company, and implement necessary changes to maintain compliance. They are responsible for setting the company's standards for quality, safety, and efficacy.
To excel in this role, one should possess excellent analytical skills, strategic thinking, and strong leadership abilities. A deep understanding of regulatory guidelines, ability to interpret complex regulations, and excellent communication skills are essential. They should have a degree in a relevant field, along with certifications such as Regulatory Affairs Certification (RAC), Certified Quality Auditor (CQA), and Certified Quality Engineer (CQE). Prior to becoming a Director of Regulatory Affairs, individuals might have roles such as Regulatory Affairs Specialist, Regulatory Affairs Manager, or Quality Control Manager.
- Edison, NJ (21 miles from Hopewell, NJ)
- 5 hours ago
- Edison, NJ (21 miles from Hopewell, NJ)
- 5 hours ago
Gather and analyze information for product codes, device descriptions, FDA listing numbers and GMDN codes. Design, develop, test, document & support of cGxP systems as per 21CFR Part11 & US FDA....
Cybersecurity Compliance Analyst
- Basking Ridge, NJ (21 miles from Hopewell, NJ)
- 9 hours ago
- Basking Ridge, NJ (21 miles from Hopewell, NJ)
- 9 hours ago
When you join Verizon You want more out of a career. A place to share your ideas freely - even if they're daring or different. Where the true you can learn, grow, and thrive. At Verizon, we power...
- New Brunswick, NJ (18 miles from Hopewell, NJ)
- 4 days ago
- New Brunswick, NJ (18 miles from Hopewell, NJ)
- 4 days ago
Company: Kelly Services Location: New Brunswick, NJ Career Level: Associate Industries: Recruitment Agency, Staffing, Job Board Description At Kelly Professional & Industrial, we're all about...
- New Brunswick, NJ (18 miles from Hopewell, NJ)
- 5 days ago
- New Brunswick, NJ (18 miles from Hopewell, NJ)
- 5 days ago
At Kelly Professional & Industrial, were all about helping you discover whats next in your career. Are you a recent graduate with a keen eye for detail and a passion for data analytics? Do you...
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- Trenton, NJ (13 miles from Hopewell, NJ)
- 17 days ago
- Trenton, NJ (13 miles from Hopewell, NJ)
- 17 days ago
. + Own audit readiness and guide teams through federal and state exams, internal audits, and testing processes with confidence and clarity. + Turn insights into action by analyzing results, delivering...
Remote WorkSenior Regulatory Affairs Specialist
- Bridgewater, NJ (15 miles from Hopewell, NJ)
- 30+ days ago
- Bridgewater, NJ (15 miles from Hopewell, NJ)
- 30+ days ago
Join a team! We are a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of...
Compliance Analyst / NIST / Greater Philadelphia Area Only
- Huntingdon Valley, PA (24 miles from Hopewell, NJ)
- 45+ days ago
- Huntingdon Valley, PA (24 miles from Hopewell, NJ)
- 45+ days ago
This local data management company is looking for a Compliance Analyst to join their team. This person will be involved with a wide range of risk and audit engagements, mostly in the government...
Regulatory Compliance Specialist (9891)
- Morrisville, PA (14 miles from Hopewell, NJ)
- 45+ days ago
- Morrisville, PA (14 miles from Hopewell, NJ)
- 45+ days ago
Grow a Better Tomorrow with Nufarm. We know that growing is about more than just crops and cultivation. It's about sunshine and rain, early mornings and hard work. It can be frustratingly...
Demographic Data for Hopewell, NJ
Moving to Hopewell, NJ? Find some basic demographic data about Hopewell, NJ below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Hopewell, NJ
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Hopewell, NJ offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Finance
- Internal Control
- Reimbursement
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- Corrective Actions & Preventive Actions
- ISO 13485
- Validation
- Medical Device Sales
- Business Processes
- FDA Regulations
- Document Management
- Resolution
- Microsoft SharePoint
- Product Development
- Risk Management
- Engineering
- Strategy Development
- Process Improvement
- Military Background
- Implementation
- Auditing
- Analytical Skills
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Data Analysis
- Collaboration
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Reporting
- Microsoft PowerPoint
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Time Management
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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